Description
Release form
suspension for injection
Packaging
5 cartridges of 3 ml.
Pharmacological action
Humulin Regular – human recombinant DNA insulin. It is a medium-acting insulin preparation. The main effect of the drug is the regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle and other tissues (with the exception of the brain), insulin causes rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin promotes the conversion of glucose to glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose to fat.
Pharmacokinetics
Humulin Regular is a short-acting insulin preparation.
The onset of action of the drug is 30 minutes after administration, the maximum effect is between 1 and 3 hours, the duration of action is 5-7 hours.
Individual differences in insulin activity depend on factors such as dose, choice of injection site, physical activity of the patient.
Indications
diabetes mellitus if indicated for insulin therapy
newly diagnosed diabetes mellitus
pregnancy with type 2 diabetes mellitus (non-insulin dependent).
Contraindications
Hypoglycemia.
Hypersensitivity to insulin or to one of the components of the drug.
Use during pregnancy and lactation
During pregnancy, it is especially important to maintain good glycemic control in patients with diabetes mellitus. During pregnancy, the need for insulin usually decreases in the first trimester and increases in the second and third trimesters.
Diabetes patients are advised to inform their doctor of the onset or planning of pregnancy.
In patients with diabetes mellitus during lactation (breastfeeding), dose adjustment of insulin, diet, or both can be required.
In studies of genetic toxicity in the in vitro and in vivo series, human insulin did not exert a mutagenic effect.
Special instructions
Transfer of the patient to another type of insulin or to an insulin preparation with a different brand name must occur under strict medical supervision. Changes in the activity of insulin, its type (for example, M3, NPH), species (porcine, human insulin, human insulin analogue) or production method (DNA recombinant insulin or insulin of animal origin) may require dose adjustment.
The need for dose adjustment may be required already at the first administration of a human insulin preparation after an animal insulin preparation or gradually over the course of several weeks or months after transfer.
Insulin demand may decrease with insufficient adrenal function, pituitary or thyroid gland, with kidney or liver failure.
With some illnesses or emotional stress, the need for insulin may increase.
Dose adjustment may also be required with increased physical activity or with a change in normal diet.
Symptoms of the precursors of hypoglycemia during administration of human insulin in some patients may be less pronounced or different from those that were observed during administration of animal insulin. With normalization of blood glucose levels, for example, as a result of intensive insulin therapy, all or some of the symptoms that precursor to hypoglycemia may disappear, which patients should be informed about.
Symptoms of the precursors of hypoglycemia may change or be less pronounced with prolonged diabetes mellitus, diabetic neuropathy, or with the use of beta-blockers.
In some cases, local allergic reactions can be caused by reasons not related to the action of the drug, for example, skin irritation with a cleansing agent or improper injection.
In rare cases of systemic allergic reactions, immediate treatment is required. Sometimes, insulin changes or desensitization may be required.
Effect on the ability to drive vehicles and control mechanisms
During hypoglycemia, the patient’s ability to concentrate and decrease the rate of psychomotor reactions may decrease. This can be dangerous in situations in which these abilities are especially necessary (driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent symptoms-precursors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the doctor must evaluate the feasibility of the patient driving the car.
Composition
1 ml suspension for injection contains: active substance: soluble insulin (human genetic engineering) 100 IU,
excipients: metacresol, glycerol, water for injection, hydrochloric acid (10% solution) and / or sodium hydroxide (10% solution) to create the required pH level.
Dosing and Administration
The dose is determined by the doctor individually, depending on the level of glycemia.
The drug should be administered subcutaneously, possibly intramuscularly. Intravenous administration of Humulin Regular contraindicated!
Subcutaneously, the drug is administered to the shoulder, thigh, buttock or abdomen. The injection site must be alternated so that the same place is used no more than about 1 time / month.
When administered subcutaneously, care must be taken to avoid entry into a blood vessel. After the injection, the injection site should not be massaged. Patients should be trained in the proper use of insulin devices.
Rules for the preparation and administration of the drug
Humulin cartridges and vials The regular before use should be rolled between the palms 10 times and shaken, turning 180 ° also 10 times to resuspend insulin until it becomes a uniform turbid liquid or milk. Shake vigorously, as this can lead to the appearance of foam, which can interfere with the correct dose.
Cartridges and vials should be checked carefully. Do not use insulin if it contains flakes after mixing, if solid white particles adhere to the bottom or walls of the vial, creating the effect of a frosty pattern.
The cartridge device does not allow their contents to be mixed with other insulins directly in the cartridge itself. Cartridges are not intended to be refilled.
The contents of the vial should be poured into an insulin syringe corresponding to the concentration of insulin administered and the desired dose of insulin should be administered as directed by your doctor.
When using cartridges, follow the manufacturer’s instructions for refilling the cartridge and attaching the needle. The drug should be administered in accordance with the instructions of the manufacturer of the syringe pen.
Using the outer cap of the needle, unscrew the needle immediately after insertion and destroy it safely. Removing the needle immediately after injection ensures sterility, prevents leakage, air ingress and possible clogging of the needle. Then put the cap on the handle.
Needles should not be reused. Needles and syringe pens should not be used by others. Cartridges and vials are used until they become empty, after which they should be discarded.
Humulin Regular can be administered in combination with Humulin NPH. For this, short-acting insulin should be drawn into the syringe first to prevent longer-acting insulin from entering the vial. It is advisable to introduce the prepared mixture immediately after mixing. To administer the exact amount of each type of insulin, you can use a separate syringe for Humulin Regular and Humulin NPH.
You should always use an insulin syringe that matches the concentration of insulin you injected.
Side effects
Side effect associated with the main effect of the drug: hypoglycemia.
Severe hypoglycemia can lead to loss of consciousness and (in exceptional cases) death.
Allergic reactions: local allergic reactions are possible – hyperemia, swelling or itching at the injection site (usually stop within a period of several days to several weeks) systemic allergic reactions (occur less often, but are more serious) – generalized itching, shortness of breath, shortness of breath , decreased blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions can be life threatening.
Other: the likelihood of developing lipodystrophy is minimal.
Drug interaction
Hypoglycemic effect of Humulin Regular decrease oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, tricyclic antidepressants.
Hypoglycemic effect of Humulin The oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol and ethanol-containing drugs increase the hypoglycemic effect of Humulin.
Beta-blockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.
Pharmaceutical Interactions
Effects, arising from the mixing of human insulin with insulin of animal origin or human insulin produced by other manufacturers have not been studied.
Overdose
Symptoms: hypoglycemia, accompanied by lethargy, increased sweating, tachycardia, pallor of the skin, headache, tremors, vomiting, confusion.
Under certain conditions, such as long duration or intense diabetes control, the symptoms of hypoglycemia may change.
Treatment: mild hypoglycemia can usually be stopped with glucose (dextrose) or sugar. Adjustment of insulin dose, diet, or physical activity may be required.
Correction of moderate hypoglycemia can be performed by intramuscular or subcutaneous administration of glucagon, followed by intake of carbohydrates.
Severe hypoglycemia, accompanied by coma, convulsions or neurological disorders, is stopped by intramuscular or subcutaneous administration of glucagon or by intravenous administration of a concentrated glucose solution (dextrose). After regaining consciousness, the patient should be given carbohydrate-rich foods to avoid hypoglycemia.
Storage conditions
The product should be stored in the refrigerator at 2 ° C to 8 ° C, to prevent freezing and to avoid direct exposure to light.
active substance
Insulin soluble human genetically engineered
Terms leave through pharmacies
In retseptu
dosage form
solution for injection
